Quality Systems Engineer

Job Overview

Quality Systems Engineer
Based in Athlone

Excellent opportunity for a Quality Systems Engineer to join a leading and rapidly growing worldwide provider of advanced healing technologies. Based in the beautiful Athlone, my client is the world's largest medical device company in its sector, and they are very unique in what they do with a demonstrated history of innovation and advancing technology by introducing first-of-kind solutions to market.
This company has invested heavily into their Athlone facilities which shows their long-term commitment to employees and the area. They pride themselves in recruiting, developing, and retaining the best people as they continue to grow. We are delighted to partner with this Company in helping them find the best talent to join their expanding teams.
The atmosphere is friendly, down to earth and all employees are supported by peers and managers.

You will provide quality systems support for all the processes related to QMS and ensure quality standards are being met and lead the implementation of and compliance to the Quality Management program and support company goals.

Responsibilities of Quality Systems Engineer:

  • Create, manage and maintain controlled document stations (CDS) including suppliers as necessary.
  • Manage the change control system and train staff on change order processes.
  • Assist in creating and processing change orders including risk assessment and validation requirements.
  • Tracking and management of change orders and generate management metrics on change order system.
  • Coordinate with the Quality Systems Manger to prepare maintain and execute the audit schedule and any subsequent actions.
  • Preparing Metrics on Internal Audits and coordinate review meetings.
  • Prepare metrics and analyse results following internal audits.

Requirements of Quality Systems Engineer:

  • Degree in Engineering, Science or related discipline.
  • Min 5 years experience in a similar role within a highly regulated industry.
  • Working knowledge of FDA and ISO quality systems such as ISO9001, ISO14001 and/or ISO13485.
  • Strong document management skills

For more information or to discuss your suitability for the role please call Aoife on 086 044 3981.

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